COMPENDIUM ON FUNCTIONAL MEDICINE - Flipbook - Page 88
popular misconception, you do not need to be a physician to
legally order or interpret laboratory tests. Federal law establishes
that individuals have the legal right to order and interpret
laboratory test results for themselves or others, provided they do
not engage in the diagnosis or treatment of disease without
appropriate licensure [1].
This right is protected through the Health Insurance Portability and
Accountability Act (HIPAA) provisions on individual access to
health data and has been reinforced by subsequent regulatory
changes. The 2014 amendments to HIPAA and the Clinical
Laboratory Improvement Amendments (CLIA) regulations marked
a crucial turning point, formally granting individuals direct access
to their test results from laboratories [2].
Evolution of Direct Access Testing (DAT)
From Restriction to Empowerment
Throughout most of the 20th century, laboratory testing was tightly
regulated, with access typically restricted to MDs and DOs.
Non-physician providers faced significant barriers despite
possessing advanced clinical knowledge. The paradigm began
shifting in the early 2000s when consumer-oriented approaches to
healthcare gained momentum [3].
As of 2025, more than 35 U.S. states allow full or partial access to
Direct Access Testing (DAT), enabling individuals to order tests
such as complete blood counts, hormone panels, stool analysis,
and micronutrient testing without physician referral [4]. This
democratization has significantly expanded access to functional
and preventive care.
Legal Framework Supporting Direct Access
The foundation for this expanded access includes:
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